Domestic Oven Gloves – CE Mark – PPE Updates

Effective April 21, 2018, domestic oven gloves and mitts will be classified as Personal Protective Equipment (PPE) and regulated under the new PPE regulation 425/2016/EU. This regulation will repeal and replace Directive 89/686/EEC.

PPE, Personal Protective Equipment, is defined as equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety. Following the approval of Regulation 425/2016/EU, oven gloves and mitts have been categorized for risk as Category II PPE and are therefore required to carry the CE mark and Conformity Assessment by a Notified Body before they can be sold in the EU.

Manufacturers and sellers of such products should start the process of designing and testing their product before the deadline and must be familiar with the requirements of the Contact Heat test: ISO 12127-1, and the essential health and safety requirements for gloves including labelling. However, during the implementation process, it takes time for Notified Bodies to become approved to the new Regulation and also, EN 407 – “Protective gloves against thermal risks” is being reviewed at CEN level and no date has yet been set for it to be published and harmonized. Therefore, SGS has produced the following list of recommendations that will support producers to design and fabricate products to comply with the new requirements for gloves and are safe for use in a domestic oven.

SGS UK Ltd suggests using some clauses of BS 6526 as a good start and supplementing with the new test method: ISO 12127-1 at a temperature of 250°C as required by EN 407 for the palm area of the hand. SGS also suggests that in order to meet the “essential health and safety requirements” for PPE gloves, the back of the hand should also be protected against hot contact. The details of back of hand protection have not been defined, but SGS recommends that the palm requirements be used.

Previously, such gloves would have been tested only in the new state, but under PPE rules, the protection level has to be maintained throughout its useful life. This means that if the glove is washable, then the number of washes it can withstand has to be known and stated in the literature accompanying the product. This adds a responsibility to the manufacturer to be able to demonstrate that after a specified number of washes, all properties including the Contact Heat requirement are maintained.

Below is SGS opinion on what will be required from compliant domestic oven gloves under the new regulation.

The manufacturer/retailer will have to decide how many washes are reasonable for the useful life of the product based on their market knowledge. Currently SGS is suggesting 25 should meet this need.

It has been clarified that existing products already in the supply chain can continue to be sold after the April deadline, but any new product introduced in to the supply chain on or after the April 21, 2018 should be compliant with the new regulation and be CE Marked accordingly.

In order to achieve certification for the use of the CE Mark, a Technical File has to be assembled and submitted to a Notified Body approved for the purpose, and this has to be reviewed against the essential health and safety requirements by the Notified Body before certification is granted. Please refer to our SafeGuards No. 028/17 [1] for the list of requirements in the Technical File.

Marking should be on the product itself or on labels attached to the product.

Under the PPE regulation the standard CE Mark shall be used, examples of which are shown below:

The Notified Body number should not be used as it is a Category II product.

It is not possible to use the pictogram for EN407 as the product cannot meet the requirements of the normative reference of EN 420.

However it shall include:

Name, trademark or other means of identification of the manufacturer or his authorised representative

Designation of the product type, commercial name or code

Durable to the appropriate number of cleaning processes

If the manufacturer intends to indicate on the marking that the manufacturer’s instructions have to be consulted, then the following shall be used.

The manufacturer’s instructions for use shall meet the requirements of Clause 1.4 of Annex II of Regulation 425/2016/EU.

In addition to the name and address of the manufacturer, the instructions that must be supplied with the PPE must contain all relevant information on:

(a) Instructions for storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions

(b) Performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE

(c) Where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts

(d) Where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use

(e) Where applicable, the month and year or period of obsolescence of the PPE or of certain of its components

(f) Where applicable, the type of packaging suitable for transport

(g) The significance of any markings

(h) The risk against which the PPE is designed to protect

(i) The reference to this regulation and, where applicable, the references to other union harmonisation legislation

(j) The name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE

(k) References to the relevant harmonised standard(s) used, including the date of the standard(s), or references to the other technical specifications used

(l) The internet address where the EU declaration of conformity can be accessed

The information referred to in points (i), (j), (k) and (l) need not be contained in the instructions supplied by the manufacturer if the EU declaration of conformity accompanies the PPE.

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